Bioelectronics Corp (BIEL)

[GetSeriousOK]

"Will Ilfeld publish his data?"

I don't know. Probably. He published the phantom pain data. He might wait for the SofPulse study to end first and publish them together, or he might publish the ActiPatch study separately.

But let's assume he DOES publish the ActiPatch study in October. (six months is how long he took for the phantom pain study.) The QUESTION is: will the CMS decide that Ilfeld's results "demonstrated the ability to replace, reduce, or avoid opioid use or the quantity of opioids prescribed?"

Ilfeld clearly stated in the excerpt I quoted that HE doesn't think so. If/when he publishes the data, he's not going to say the study "showed statistical significance" which means it didn't demonstrate anything other than that a larger trial is justified. And if Ilfeld doesn't think his Pilot Study proved anything, will the CMS think it did? Staelin will describe the trial as demonstrating opioid reduction, but will the CMS listen to Ilfeld or Staelin?

I don't know the answer. There ARE those who insist that Ilfeld's study WILL provide the necessary proof. I'm not insisting anything. There is certainly the possibility that the CMS will be pressured by politicians to give the ActiPatch and many other devices and drugs the benefit of the doubt because they want MORE devices and drugs to be included in the NOPAIN Act.

That was not the point of my post though. My point was that Kelly Whelan was asked point blank what she is doing to prepare for the NOPAIN Act, and you saw her answer.